Incyte’s Opzelura (ruxolitinib) Receives EC’s Approval for Non-Segmental Vitiligo with Facial Involvement in Adults and Adolescents
Shots:
- The EC has granted marketing authorization for Opzelura (15mg/g) to treat adults & adolescents aged ≥12yrs. The EC decision was based on the P-III trials (TRuE-V1 & V2) evaluating Opzelura vs vehicle in 600+ patients aged ≥12yrs.
- The results showed an improvement in facial & total body repigmentation as shown by the no. of patients who reached F-VASI-T-VASI EPs @24wk. & in an OLE @52wk.
- ≥75% improvement from baseline in F-VASI75 in both studies (29.8% & 30.9% vs 7.4% & 11.4%), respectively while one in two patients achieved F-VASI75 @52wk. & one in three @52wk., ≥15% vs ~2% achieved ≥90% improvement in F-VASI (F-VASI90) @24wk., no serious TRAEs related to ruxolitinib were reported. The EC’s decision applies to all 27 EU Member States, Iceland, Norway & Liechtenstein
Ref: - Businesswire| Image: - incyte
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